Contamination and Adulteration: Protection Through Testing

by Kerri LeVanseler, Ph.D.

Recently, contamination and adulteration of products received a great deal of attention within the United States and on a global level. Examples include salmonella in peanut butter, E. coli in spinach, melamine in pet food and infant formula, and diethylene glycol (DEG) in products formulated with glycerine. Residual levels of pesticides, dioxin, heavy metals, aflatoxin and allergens are an ongoing concern. In the botanical area, collection of the incorrect plant can have toxic consequences. Also, with segments of the population looking for easy natural ways to enhance their bodies, unscrupulous manufacturers may take an herbal-based blend and add steroids, stimulants or pharmaceutical actives to the material in an attempt to make the blend really work. The product now becomes illegal, with undeclared ingredients that may be banned under government regulations, containing unapproved food additives or new dietary ingredients. Products such as these lack thorough safety testing prior to sale and do not have the proper labeling that is required for foods, dietary supplements or drugs.

What should companies do to protect their products and their reputation? Companies must take action to mitigate their risk by establishing testing programs and partnering with suppliers that practice GMPs (good manufacturing practices) to develop traceability programs for their ingredients. Since the media plays such a strong force in impacting consumer-purchasing decisions, news of a product recall can have long-lasting negative effects for companies that become associated with the recall. Any quality system must take into consideration the acceptability of incoming materials in order to ensure a high-quality final product. Proposed tests and assessments must take into account possible risks and ensure the method utilized is sensitive and selective for the adulterant or contaminant of concern. GMP principles emphasize this, and history has shown trusting a suppliers certificate of analysis is just not enough. Evaluation of materials for contamination and adulteration is a critical component for maintaining a viable business in the dietary supplement industry.

Some contaminants can be considered accidental. For example, environmental exposure can lead to contamination in raw materials, as would be the case with some pesticide exposure, dioxin or heavy metals. Such materials were not intentionally added into the product; however, the lack of intent does not prevent such contaminants from being a considerable safety factor for consumers. The costs of testing for these contaminants is variable, with heavy metals the most economically priced and Dioxin and PCB testing fairly high priced; near $1,500 to $2,000 per sample. It is important to purchase from reputable suppliers that monitor these contaminants in their raw materials. Nonetheless, further processing of the raw materials may result in concentration of the residues or it may decrease the concentration of the contaminants. Consideration of these contaminants is an important aspect of developing a solid GMP program.

Cases of intentional adulteration for economic gain appear to be on the rise. When the balance of the supply and demand shifts, price increases of natural materials can occur. Non-ethical suppliers may attempt to switch out less expensive materials (e.g., blueberries for bilberry; adding rutin to ginkgo), with knowledge of testing loopholes; some can get away with it, unless testing is designed to weed out this type of cheating. Economic motivation was behind the DEG contaminations, heparin contamination and, most notoriously, the melamine recalls. All situations were allowed to happen since the test methods employed did not have the selectivity necessary to detect even high levels of these contaminants. With knowledge of these incidents, it is fairly easy to set up tests to ensure these contaminants are not present; but, what about un-anticipated contaminants? A risk assessment connected with GMP specification development will help to identify areas where non-selective test methods for highly priced ingredients may present an open door for adulteration. These doors need to be closed prior to a disastrous situation, not in response to it.

In the case of steroid or stimulant adulteration in products targeted for athletes, it is unfortunately very common for top-level athletes to point the finger back at a dietary supplement when a urine test comes back positive. The use of Liquid Chromatography Mass Spectrometry (LC-MS) and Gas Chromatography Mass Spectrometry (GC-MS) screens can be effective in ensuring banned substances are not present in supplements prior to them going into the hands of the athlete.

Regulatory agencies must have information about illegal products to allow for their removal from the marketplace. Products that are labeled in a fashion consistent with their contents, meeting the regulatory framework for that product category and tested for possible contamination would adequately protect the consumer from unknown threats to their health.

Kerri LeVanseler, Ph.D., technical manager of the chemistry laboratory at NSF International , contributes to process improvements and new business development, acts as a coordinator for the Good Laboratory Practices (GLP) Program, participates in R&D of new methods, coordinates quality assurance efforts, supervises chemistry staff for special projects, and resolves special technical issues.

Want to learn more about the ensuring quality through laboratory testing? Join Kerri LeVanseler, Ph.D., for the session Contamination & Adulteration: Protection Through Testing on Nov. 12, 2009, at SupplySide West. Get more details at SupplySideShow.com/West .